NCT06789406 PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
| NCT ID | NCT06789406 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Axonics, Inc. |
| Condition | Urinary Urge Incontinence (UUI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2025-09-18 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 55 participants in total. It began in 2025-09-18 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.
Eligibility Criteria
Inclusion Criteria: 1. 18 years or older 2. Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment 3. Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments Exclusion Criteria: 1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (i.e., neurological conditions such as multiple sclerosis) 2. Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements 3. Previously underwent an external sacral neuromodulation SNM trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder) 4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone 5. A female who is breastfeeding 6. A female with a positive urine pregnancy test
Contact & Investigator
Mahreen Pakzad, MD
PRINCIPAL INVESTIGATOR
University College London Hospitals
Frequently Asked Questions
Who can join the NCT06789406 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urinary Urge Incontinence (UUI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06789406 currently recruiting?
Yes, NCT06789406 is actively recruiting participants. Contact the research team at anna.selverian@bsci.com for enrollment information.
Where is the NCT06789406 trial being conducted?
This trial is being conducted at Chicago, United States, Columbia, United States, Bradford, United Kingdom, Wakefield, United Kingdom and 1 additional location.
Who is sponsoring the NCT06789406 clinical trial?
NCT06789406 is sponsored by Axonics, Inc.. The principal investigator is Mahreen Pakzad, MD at University College London Hospitals. The trial plans to enroll 55 participants.